• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDR. BROWN'S HOME DRUG TESTING KIT
Classification Nameenzyme immunoassay, cannabinoids
Generic Namespecimen collection kit
Regulation Number862.3870
ApplicantPERSONAL HEALTH & HYGIENE, INC.
PMA NumberP950040
Date Received12/19/1995
Decision Date01/21/1997
Product Code
LDJ[ Registered Establishments with LDJ ]
Docket Number 97M-0257
Notice Date 06/30/1997
Advisory Committee Toxicology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for dr. Brown's home drug testing system. Dr. Brown's home drug testing system is an over-the-counter collection and transport system intended for use by individuals wishing to anonymously test urine samples for drugs of abuse (marijuana, cocaine, amphetamine, methamphetamine, phyencyclidine (pcp), codeine, and morphine).
Supplements: S001 S002 S003 
-
-